Sequential Therapy of Atorvastatin Improve Outcomes of ST-elevated Acute Myocardial Infarction

Not Applicable

• Conditions: Acute Myocardial Infarction
• Interventions: Drug: Sequential therapy of atorvastatin

• Registration Number: NCT01997294
• Lead Sponsor: Zhang Qi, MD

Brief Summary

Statins have been approved to benefit patients underwent percutaneous coronary intervention (PCI). The current study is designed to evaluate the effectiveness and safety of Sequential Therapy of Atorvastatin in patients with ST-elevated myocardial infarction and receive PCI treatment.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2013-11-22
• Study First Submitted QC: 2013-11-27
• Study First Posted: 2013-11-28
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-09
• Last Update Posted: 2016-10-11
• Primary Completion: 2017-02
• Study Completion: 2017-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1200

Inclusion Criteria

• Sighed informed consent
• Diagnosised as acute myocardial infarction
• Time frame less than 12 hours since the occurance of chest pain
• Aggred to receive sirolimus-eluted coronary stents
• Patients willing to accepte follow-up

Exclusion Criteria

• Allegy to statins or with a history against statin therapy
• Allegy to any products that will be used during PPCI
• Disagreed to receive PPCI and other related therapy
• Existing sever liver dysfuntion that statins can not be used according to the guildlines
• Sever kidney dysfunction (creatinine >3mg/dl or eGFR<30ml/min)
• Sever left ventricular dysfunction (Killip grade 3)
• Patients are currently taking medicine that may influence the use of statin
• Patients with a history of alcohol abuse or durg abuse
• Woman during pregnancy or lactation
• Patients who has attended other clinical trials
• Patients who has received PCI or CABG previously
• Patients who can not agree to accept study protocol
• Other conditions that may not sutible for the current study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
sequential therapy group	Sequential therapy of atorvastatin	80mg atorvastatin before primary PCI (PPCI) followed by 40mg/d for 7 days after PPCI followed by 20mg/d for 1 year
Usual Therapy of atorvastatin	Sequential therapy of atorvastatin	20mg/d before and after PPCI for 1 year

Primary Outcome Measures

Name	Time	Method
Major Adverse Events (MACE) Occourance Rate	30 days	1. Cardiac Death (CD); 2. Non-fatal re-inarction (CK-MB, cTNI or cTNT elevation again and over 3 times higher than up normal limit accompanied with syptoms or EKG indication); 3. revascularization driven by syptoms (CABG or re-PCI)

Secondary Outcome Measures

Name	Time	Method
Secondary Endpoints	12 months	1. TMP and TIMI grade chage after stents implantation; EKG ST reduction; 2. MACE ( same definition as primary endpoints)

Trial Locations

Locations (1)

Ruijin Hospital, Dept. of Cardiology; 🇨🇳 Shanghai, Shanghai, China